FDA Recommends Approval of Ultrasound Cancer Screening System

The U.S. Food and Drug Administration (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee has recommended approval of the somo-v Automated Breast Ultrasound (ABUS) system. Developed by U-Systems, the somo-v currently has FDA clearance to be used as a diagnostic aid to mammography, but the company is seeking premarket approval (PMA) to use the system as a cancer-screening tool.

Although the FDA is not obligated to follow the recommendation of review panels, it usually does. If PMA is granted for the somo-v, it would make the system the only ultrasound device in the United States approved for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. Studies indicate that dense breast tissue elevates the risk of breast cancer between four-fold and six-fold, but it also makes the detection of cancer more difficult, as the denser tissue hides possible tumors. Mammograms alone are not a sufficient diagnostic tool in women with dense tissue; U-Systems claims that its somo-v not only can detect hard-to-see tumors, but also can detect them earlier.

Rachel Brem, M.D., director of breast imaging at George Washington University Hospital in Washington D.C., said hard-to-detect tumors make up approximately 30 percent of all tumors. The president and CEO of U-Systems added that “at least 40 percent of women in the United Stated have dense breast tissue.”

Usystems specifically is involved in the manufacture and marketing of ultrasound technology geared towards early cancer detection. The company is based in Sunnyvale, Calif.